Generic Name:
Esomeprazole

Composition:
• Each capsule contains Esomeprazole Magnesium USP equivalent to Esomeprazole 40 mg, as enteric-coated pellets.

Pharmacology:
• Esomeprazole is a proton pump inhibitor (PPI) that suppresses gastric acid secretion by specifically inhibiting the H+/K+-ATPase enzyme in gastric parietal cells.
• Esomeprazole is the S-isomer of omeprazole and is a single optical isomer of a proton pump inhibitor.

Indications:
• Healing of erosive esophagitis.
• Maintenance of healing of erosive esophagitis.
• In combination with amoxicillin and clarithromycin for eradication of Helicobacter pylori infection in patients with duodenal ulcer disease.
• Zollinger–Ellison syndrome.
• Acid-related dyspepsia.
• Duodenal and gastric ulcers.
• Symptomatic gastroesophageal reflux, as described in the product insert.

Dosage & Administration:
• Healing of erosive esophagitis: 20 mg or 40 mg once daily for 4–8 weeks. For patients who do not heal after 4–8 weeks, an additional 4–8 weeks of treatment may be considered.
• Maintenance of healing of erosive esophagitis: 20 mg once daily. The insert states that clinical studies did not extend beyond 6 months.
• Symptomatic reflux: 20 mg once daily for 4 weeks. If symptoms do not resolve completely, an additional 4 weeks may be considered.
• Helicobacter pylori eradication: Triple therapy for 10 days—Esomeprazole 40 mg once daily, Amoxicillin 1000 mg twice daily, and Clarithromycin 500 mg twice daily.
• Zollinger–Ellison syndrome: 20–80 mg once daily; adjust individually according to clinical requirements.
• Acid-related dyspepsia: 20–40 mg once daily for 2–4 weeks, according to response.
• Duodenal ulcer: 20 mg once daily for 2–4 weeks.
• Gastric ulcer: 20–40 mg once daily for 4–8 weeks.
• Dosage and duration should be determined by the prescribing physician.

Contraindications:
• Contraindicated in patients with known hypersensitivity to any component of the formulation.

Side Effects:
• Headache.
• Diarrhoea.
• Nausea.
• Flatulence.
• Abdominal pain.
• Constipation.
• Dry mouth.

Precautions:
• When gastric ulcer is suspected, exclude the possibility of malignancy before treatment.
• When used in combination with antibiotics, refer to the prescribing information for the respective antibiotics.

Use in Pregnancy & Lactation:
• Pregnancy Category B, as stated in the supplied insert.
• There are no adequate and well-controlled studies in pregnant women.
• Animal studies have revealed no teratogenic effects.
• The insert states that the excretion of esomeprazole in human milk has not been studied. Breast-feeding should be discontinued if treatment is considered essential, according to the insert.

Drug Interactions:
• Esomeprazole may affect hepatic clearance through inhibition of the cytochrome P-450 monooxygenase system.
• The insert notes uncertainty regarding its effect on the combined oral contraceptive pill.
• Reduced gastric acid may influence bacterial colonisation of the stomach and duodenum and vitamin B12 absorption.

Overdose:
• The overdose information in the supplied insert is incomplete. Confirm the approved wording with PMD before publication.
• The insert states that treatment in the event of overdosage should be symptomatic and supportive.

Storage:
• Store below 30°C, protected from light and moisture.
• Store in a dry and cool place.
• Keep out of reach of children.

Dosage Form:
• Capsule containing enteric-coated pellets.

Commercial Packaging:
• Each box contains 50 capsules in an Alu-Alu blister pack.